Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study

Nanjing Medical University

Status: Not yet enrolling

Conditions: Diabetic Gastroparesis; Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus; Diabetic Gastroenteropathy; Diabetic Gastropathy

Treatments: Other: Washing Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06340828

2023-KY-186-01

Details and patient eligibility

About

The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:

• The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
• The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
• The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
• The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.

Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
• Glycated hemoglobin (HbA1c) < 11.0%.

Exclusion criteria

• Insulin dependent diabetes;
• Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
• Severe diabetic complications;
• Thyroid disease, malignancies, severe cognitive impairment and mental disease;
• Alcohol or substance abuse;
• Pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Washing Microbiota Transplantation (WMT) group

Experimental group

Description:

After assessing the general condition and gastrointestinal symptoms of the patients upon admission, consecutive days of washing microbiota transplantation were conducted. The administration time was 3 p.m., administered via a nasogastric tube at a dosage of 50 ml per administration. A follow-up appointment at the hospital was scheduled for week 12 post-treatment to reinforce the therapeutic effect with a second treatment, following the same timing, dosage, and administration route as the first treatment.

Treatment:

Other: Washing Microbiota Transplantation